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Not yet recruitingNCT06029608Updated Oct 2, 2025

Evaluation of the Efficacy and Safety of Magnetically-controlled Capsule Gastroscopy for Postoperative Assessment in Elderly Patients and Patients With Underlying Diseases

An observational study in Evaluation,Efficacy,Safety, sponsored by Shanghai Jiao Tong University School of Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-02.

Sponsored by Shanghai Jiao Tong University School of Medicine · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
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Study summary

The objective of this prospective, observational, controlled clinical study is to use magnetically-controlled capsule gastroscopy for postoperative assessment in elderly patients and patients with underlying diseases, to evaluate its clinical efficacy and safety.

Read the detailed description

Gastric cancer is the most common digestive tract malignancy in China, which severely impacts human health and quality of life. Currently, surgery is the main treatment for gastric cancer. Since the surgery removes part or all of the stomach for malignant tumor, various postoperative complications inevitably occur. The occurrence of postoperative complications is detrimental to the prognosis of patients. Therefore, regular follow-up after surgery is necessary to closely monitor for upper gastrointestinal symptoms and periodically examine intragastric lesions in order to make timely diagnosis and treatment, and improve quality of life. Standard endoscopy procedures often cause discomfort and poor compliance in elderly patients. Also, for patients with severe respiratory diseases, severe cardiocerebral vascular diseases, the risks of anesthesia are extremely high. Magnetic-controlled capsule gastroscopy has the advantages of being completely painless, convenient, highly accurate in diagnosis, and well-accepted by patients. It is more suitable for postoperative assessment in elderly patients and patients with underlying diseases.

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Conditions studied

  • Evaluation,Efficacy,Safety

Keywords

  • Magnetically-controlled Capsule Endoscopy
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In context

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Elderly patients (older than 65 years) and patients with underlying diseases (cardiovascular, respiratory, hemorrhagic diseases, etc.) who underwent surgery for gastric malignant tumors (including surgical resection and ESD).

Inclusion criteria

  • Planned to undergo magnetic-controlled capsule gastroscopy or conventional endoscopy, and have undergone surgery for gastric malignant tumors (including surgical resection and ESD), elderly patients (older than 65 years) or patients with underlying diseases (cardiovascular, respiratory, hemorrhagic diseases, etc.);
  • Agree to participate in this clinical trial and sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

  • No surgical conditions or refuses abdominal surgery (Once the capsule is stuck it cannot be removed surgically);
  • Cardiac pacemakers (except MRI-compatible ones);
  • Electronic implants or metal foreign bodies;
  • Pregnant women;
  • Known or suspected GI obstruction, stenosis, fistula;
  • Dysphagia.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • Magnetically-controlled Capsule endoscopy group

    Using magnetic-controlled capsule gastroscopy for postoperative assessment in elderly patients and patients with underlying diseases

  • Conventional endoscopy group

    Using conventional endoscopy for postoperative assessment in elderly patients and patients with underlying diseases

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What researchers measure

Primary outcomes

  1. Detection of gastric lesions (or postoperative complications)

    Detection of gastric lesions (or postoperative complications)

    Time frame: 1 day

Secondary outcomes

  1. Upper gastrointestinal discomfort symptoms or not

    Patients have or no upper gastrointestinal discomfort symptoms after surgery (such as nausea, vomiting, acid reflux, belching, bloating, postprandial fullness, and early satiety), judging by the patient's chief complaint.

    Time frame: 1 day

  2. Patients' comfort during the procedure

    Use BCS to evaluate patients' comfort during the procedure (BCS is Bruggrmann comfort scale, a 5-point scale of 0 to 4, with a higher score indicating higher comfort.)

    Time frame: 1 day

  3. Gastric clarity and visibility

    Assess the clarity and visibility of the stomach. The clarity and visibility of the field of vision is divided into three categories, that is, class I: the field of vision is clear, and the part and mucosa can be accurately observed; Class II: Vision is not clear, but can still distinguish the part; Class III: Cloudy vision, unable to distinguish the area.

    Time frame: 1 day

  4. Detection of small intestinal and colonic lesions in the magnetic-controlled capsule endoscopy group

    Detection of small intestinal and colonic lesions in the magnetic-controlled capsule endoscopy group

    Time frame: 1 day

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Study locations

1 site
  • Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
    Shanghai, 200001, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06029608
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Responsible party
Xiaobo Li (Chief physician, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Sep 8, 2023
Start date
Nov 6, 2025 (estimated)
Primary completion
May 30, 2026 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
Oct 2, 2025

Study contacts

Hui-Min H Chen, MD
Contact
chenhuimin@renji.com
02168383015

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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